BARD ENDOSCOPIC OVERTUBE (#000307)

K973500 · C.R. Bard, Inc. · FED · Oct 16, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K973500
• Device Name: BARD ENDOSCOPIC OVERTUBE (#000307)
• Applicant: C.R. Bard, Inc.
• Product Code: FED · Gastroenterology, Urology
• Decision Date: Oct 16, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Indications for Use

The Bard® Endoscopic Overtube is intended to be used with an endoscope when repeated endoscopic intubation is anticipated, e.g., esophageal ligation, change of endoscopes, removal of multiple polyps and/or foreign bodies.

Device Story

Bard® Endoscopic Overtube is a medical accessory used during endoscopic procedures. It consists of a plastic sheath with a proximal flange and a distal tapered tip, inserted into the esophagus via a bite block. The device features an encapsulated stainless steel wire coil along the sheath length to maintain structural integrity and maximize the internal diameter. It is used by physicians in clinical settings to facilitate repeated endoscope insertion, protecting the hypopharynx and esophagus from trauma and the airway from aspiration during procedures like polyp or foreign body removal. The device is designed for 25 reuses.

Clinical Evidence

No clinical data. The device was evaluated through nonclinical tensile performance testing and biocompatibility testing.

Technological Characteristics

Materials: Polyvinyl chloride (PVC) sheath, stainless steel wire coil, cryolite flange. Design: Proximal flange UV-bonded to sheath, distal beveled tapered tip, encapsulated wire coil. Connectivity: None. Sterilization: Not specified. Reusability: 25 reuses.

Indications for Use

Indicated for use with an endoscope during procedures where repeated intubation is anticipated, such as esophageal ligation, endoscope exchange, or removal of polyps and foreign bodies. Intended to protect the hypopharynx and esophagus from trauma during repeated intubations and to protect the airway from aspiration.

Regulatory Classification

Identification

An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Special Controls

*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls: 1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following: 1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures. 2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use. 3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use. 2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes. 3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches 4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error. 5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program. (6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms. (7) Labeling must include: (i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified; (ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA; (iii) Identification of compatible devices; (iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification; (v) Reprocessing instructions for reusable components; (vi) A shelf life for any sterile components; (vii) A description of the device-specific use training program; (viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and (ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance. (8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include: (i) Device motion accuracy and repeatability; (ii) System testing; (iii) Instrument reliability; (iv) Crosstalk; (v) Table motion control; (vi) Thermal effects on tissue; (vii) User-device interface performance; (viii) Workspace access testing; and (ix) Performance testing with compatible devices. (9) Software verification, validation, and hazard analysis must be performed. (10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed. (11) Performance data must demonstrate the sterility of all patient-contacting device components. (12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life. (13) Performance data must validate the reprocessing instructions for the reusable components of the device. (14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible. (15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic. (16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information: (i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and (ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.

Predicate Devices

• Bard® Endoscopic Overtube (existing)
• Olympus Splinting Tube ST-C3

Submission Summary (Full Text)

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K 97 3500

pg/cg 3

Bard Interventional Products Division

C.R. Bard, Inc. 129 Concord Road P.O. Box 7031 Billerica, MA 01821-7031 508-663-8989

# BAN

OCT 16 1997

#### 510(k) Summary for the Bard® Endoscopic Overtube VI

As required by the Safe Medical Devices Act of 1990, codified under Section 513, Part (I)(3)(A) of the Act, an adequate summary of any information respecting safety and effectiveness follows.

- A. Submitter Information:
- Name and address of submitter: -Bard Interventional Products Division, C.R. Bard. Inc. 129 Concord Road, Building 3 Billerica, MA 01821

-Telephone [phone] Fax [phone]

- Contact Person: -Marion Gordon, R.A.C. Senior Regulatory Affairs Coordinator
- Date of Preparation: -October 8, 1997

## B. Device Name:

ﺖ

- Bard® Endoscopic Overtube Trade Name:
- Common/Usual Name: Overtube -
- Classification Name: Endoscope and accessories -(per 21 CFR 876.1500)

## C. Predicate Device Name:

- Trade Name: Bard® Endoscopic Overtube --
- Trade Name: Olympus Splinting Tube ST-C3

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K97 3500 pg 2 of 3

- D. Device Description:
- The Bard® Endoscopic Overtube consists of a flange bonded to a plastic sheath and is inserted into the esophagus through an initially placed bite block.
- E. Intended Use of Device:
- The Bard® Endoscopic Overtube is intended to be used with an endoscope when repeated endoscopic intubation is anticipated, e.g., esophageal ligation, change of endoscopes, removal of multiple polyps and/or foreign bodies.
- F. Technological Characteristics Summary:
- Both of the proposed and existing Bard® overtubes share a similar design consisting of a proximal cryolite flange, UV bonded to a polyvinyl chloride sheath with a distal tapered tip and is intended for use with an initially placed bite block. Both overtubes are indicated for twenty-five (25) reuses.

The proposed overtube also employs an encapsulated stainless steel tempered wire coiled along the length of its sheath and externally encapsulated within the polyvinyl chloride as does the Olympus Splinting Tube.

Similarities and Differences Summary:

- -Similarities
Both the proposed and existing Bard® overtubes share a similar design consisting of a proximal flange UV bonded to a sheath with a distal tapered tip and is intended for use with an initially placed bite block. Either device is designed to protect the hypopharynx from the trauma of repeated intubations, the airway from aspiration and the esophagus during extraction of sharp objects or foreign bodies. The labeled warnings and contraindications remain the same and both overtubes are indicated for twenty-five (25) reuses.

The proposed Bard® Endoscopic Overtube is similar in technological

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K97 3500 Pg 3 of 3

characteristic as the Olympus, Splinting Tube ST-C3, with a wire coil along the length of its sheath that is encapsulated. Additionally, an overtube has a similar intended use as a splinting tube in aiding endoscope insertion through the tube to reach a target area and perform a specific function, while the surrounding anatomy is protected from potential trauma of endoscope reinsertion.

#### Differences

- The proposed Bard® Endoscopic Overtube will be somewhat longer and the distal tip will have a beveled rather than blunt taper. The sheath will include a frosted polyvinyl chloride for a lower friction surface and will have an encapsulated coil to maximize shaft ID for repeated intubations.
- ். Performance Data:
- The Bard® Endoscopic Overtube has been subjected to nonclinical, tensile performance testing and biocompatibility testing. These tests conclude that this device is safe and effective.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three heads, representing the three branches of government. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 16 1997

Marion Gordon, R.A.C. Senior Regulatory Affairs Coordinator Bard Interventional Products Division C.R. Bard, Inc. 129 Concord Road Billerica, Massachusetts 01821-7031

Dear Ms. Gordon:

Re: K973500

Bard® Endoscopic Overtube Dated: September 15, 1997 Received: September 16, 1997 Regulatory class: II 21 CFR §876.5130/Product code: 78 KOG

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, subject to the general controls provisions of the general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predication for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for question and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours.

William Yu

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): ____K9Z3500________________________________________________________________________________________________________________________________________

____ Bard® Endoscopic Overtube________________________________________________________________________________________________________________________________________________ Device Name:

Indications For Use:

To be used with an endoscope when repeated endoscopic intubation is anticipated,
of management of the l o be used with an endoscope when repeated chaosepts in the management of management of the foreign bodies.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Division Sign-Off | Robert P. Saling |
|-------------------|------------------|
|-------------------|------------------|

Division of Reproductive, Abdominal, ENT, and Radiological Devices

| 510(k) Number | K973500 |
|---------------|---------|
|---------------|---------|

| Prescription Use | <div style="display:inline-block;">✓</div> (Per 21 CFR 801.109) |
|----------------------|-----------------------------------------------------------------|
| | OR |
| Over-The-Counter Use | ________________ (Optional Format 1-2-96) |